Immunogenicity in the phase III VOLTAIRE RCTs6–8
| Status | VOLTAIRE-RA | VOLTAIRE-CD | VOLTAIRE-PsO | |||
| Adalimumab-adbm (n=324) | Adalimumab RP (n=321) | Adalimumab-adbm (n=72) | Adalimumab RP (n=75) | Adalimumab-adbm (n=159) | Adalimumab RP (n=158) | |
| Antibody first detectable | ||||||
| ADA | Baseline | Baseline | Baseline | Week 4 | Baseline | Baseline |
| nAb | Baseline | Baseline | Week 4 | Week 4 | Baseline | Baseline |
| ADA titre at primary endpoint, median (Q1, Q3) | 16 (4, 64) at W12 32 (8, 128) at W24 | 16 (4, 64) at W12 32 (8, 96) at W24 | 16.0 (2.0, 32.0) at W4 | 2.5 (1.0, 34.0) at W4 | 32.0 (16, 128) at W16 | 32.0 (16, 128) at W16 |
| Proportion of patients with antibodies over time | ||||||
| ADA positive | * | * | ||||
| Baseline | 3.4% (11/323) | 6.5% (21/321) | 4.3% (3/69) | 0% (0/74) | 10.7% (17/159) | 10.8% (17/158) |
| Week 4 | 20.1% (64/319) | 19.9% (63/316) | 20.6% (14/68) | 5.5% (4/73) | ||
| Week 16 | 68.2% (101/148) | 71.8% (107/149) | ||||
| Week 24 | 43.6% (129/296) | 47.8% (144/301) | 69.5% (41/59) | 45.9% (28/61) | 75.3% (113/150) | 77.9% (113/145) |
| Week 48 | 41.9% (119/284) | 42.6% (120/282) | 63.5% (33/52) | 51.8% (29/56) | ||
| nAb positive | * | * | ||||
| Baseline | 2.8% (9/323) | 5.0% (16/321) | 0% (0/69) | 0% (0/74) | 0.6% (1/159) | 1.9% (3/158) |
| Week 4 | 6.6% (21/319) | 7.6% (24/316) | 8.8% (6/68) | 2.7% (2/73) | ||
| Week 16 | 54.1% (80/148) | 55.7% (83/149) | ||||
| Week 24 | 16.2% (48/296) | 20.9% (63/301) | 35.6% (21/59) | 23.0% (14/61) | 52.7% (79/150) | 57.2% (83/145) |
| Week 48 | 19.4% (55/284) | 17.7% (50/282) | 25.0% (13/52) | 19.6% (11/56) | ||
*Reported in the randomised population at baseline.
ADA, antidrug antibody; CD, Crohn’s disease; nAb, neutralising antibody; PsO, chronic plaque psoriasis; Q, quarter; RA, rheumatoid arthritis; RCTs, randomised controlled trials; RP, reference product; W, week.